Licensed Chemist

I. POSITION SUMMARY

Responsible for the conduct of physico-chemical analysis of sample materials (raw materials, in-process and finished products) to ensure adherence to all regulatory and safety standard quality.

II. DUTIES AND RESPONSIBILITIES

1. Conducts physio-chemical laboratory testing of sample materials under controlled and standardized conditions to ensure reliable results. Tests include, but not limited to:
a. Hydrogen peroxide residual determination.
b. 1st and 2nd Protocol shelf life validation.
2. Plans Quality Assurance / Quality Control (QA/QC) Programs and conducts investigation as scheduled.
3. Prepares Technical Reports, maintains records and issues Certificate of Analysis for shipments.
4. Maintains products specifications, inventory, and safekeeping including purchased material specifications especially for reagents and other chemicals needed to perform tests.
5. Recommends corrective action on customer complaints related to quality.
6. Reviews and updates QC Manual, Work Instruction and Procedures and trains QC Analysts.
7. Responsible for FDA application for CPR, LTO and Notification of Sources including preparation of documents needed in filing shipment Health Certificate.
8. Generates Monthly Monitoring Sheet for FG quality and SRF formulas
9. Maintains and updates client folders with Sales Order, COA and other records generated.
10. Performs other functions that may be assigned by supervisor from time to time or as prescribed by approved policy or guidelines.